This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: HeartWare™ HVAD™ System
PMA Applicant: Medtronic, Inc.
Address: 8200 Coral Sea Street, N.E.
Mounds View, Minnesota 55112
Approval Date: September 27, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100047S090a.pdf
What is it? The HeartWare™ HVAD™ System is a pump that helps the heart's left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. It is used in some patients who have endstage heart failure, both those who are waiting for a heart transplant and those who are not eligible to receive a heart transplant. The system consists of a blood pump that is implanted inside the patient's body and a pump controller that remains outside the patient's body. The controller is connected to the pump by a flexible tube that passes through the patient's skin. The controller is powered either by batteries or a power supply that can be connected to a standard electrical power outlet.
How does it work? The HeartWare™ HVAD™ System helps the patient's left ventricle pump blood and provide additional blood flow to the rest of the body.
Blood flows from the left ventricle into the pump through the pump inlet (where the blood enters the pump). The pump then moves blood into the main blood vessel carrying blood from the heart to the body (aorta). This is accomplished by the rotation of the pump's impeller, which speeds up the blood flow and also causes a difference in pressure between the pump inlet and outlet (where the blood exits the pump).
When is it used? The HeartWare™ HVAD™ System is designed for use both in and out of hospital settings, including during patient transport and is used when a heart failure patient's weakened heart is not capable of pumping sufficient blood to the rest of the body. The system is used as a destination therapy in patients who are not cardiac transplant candidates but are also at risk of death from end-stage heart failure that is unmanageable by standard medical therapy.
What will it accomplish? The HeartWare™ HVAD™ System will protect the heart and other parts of the body from more harm due to not enough blood flow and provide a destination treatment for patients who are not eligible to receive a heart transplant. Two clinical trials were conducted with the HeartWare™ HVAD™ System. In the first study, 164 out of 297 patients (55.2%) survived for at least 2 years on the original pump without experiencing a debilitating stroke. In the second study, 261 out of 306 patients (85.3%) survived for at least 1 year on the original pump without experiencing any stroke.
As with any major surgery, there are risks involved with the surgery to implant the HeartWare™ HVAD™ System. There are also risks and complications with the device itself, including death, stroke, infection, and bleeding.
When should it not be used? The HeartWare™ HVAD™ System should not be used in patients who cannot tolerate blood thinners (anticoagulation therapy) because these medications are required to prevent blood clots from forming in the pump.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.